GlobeImmune, Inc., today announced that initial survival data from GI-4000-02, a Phase 2b study of the company’s lead cancer product candidate, GI-4000, in subjects with resected pancreas cancer, have been accepted for oral presentation at the European Society for Medical Oncology (ESMO) 14 th World Congress on Gastrointestinal Cancer in Barcelona, Spain. Donald A. Richards, M.D., Ph.D., of Texas Oncology will present the data at 3 p.m. CET on June 27, 2012.
GI-4000, a series of four product versions based on the company’s proprietary Tarmogen® platform, targets cancers expressing mutations in the Ras protein. Each version of GI-4000 is an intact, heat-inactivated S. cerevisiae yeast expressing a unique combination of three Ras mutations, collectively targeting seven of the most common Ras mutations observed in human cancers.
GI-4000-02 is a fully enrolled, Phase 2b randomized, double-blind, placebo-controlled, multi-center adjuvant clinical trial of GI-4000 in subjects with Ras-mutated resected pancreas cancer. In this study, subjects received either GI-4000 plus gemcitabine, or placebo plus gemcitabine, as adjuvant therapy following surgical resection of their tumor. For the trial, a sample of tumor tissue was obtained from each subject during the screening period and evaluated for the presence of a Ras mutation. Only the specific GI-4000 Tarmogen containing a matching mutation in the subject’s tumor was administered. The study population consists of 176 subjects enrolled at 39 centers in the United States and five international centers between June 2006 and May 2010. The primary endpoint for this clinical trial is recurrence free survival.
Following resection, subjects were prospectively stratified into two groups by resection status as either an R1 or R0 resection. An R0 resection is defined by the absence of microscopic residual disease at the surgical margin. An R1 resection is defined by the presence of microscopic residual disease at the surgical margin. R0 and R1 patients have different expected survival rates, with R0 patients living longer on average. At this scientific congress, initial survival data for the R1 subjects will be presented.
GlobeImmune estimates that Ras mutations are found in approximately 180,000 new cancer cases each year in the United States across a spectrum of tumor types, including pancreas, non-small cell lung cancer, colorectal, endometrial and ovarian cancers as well as melanoma and multiple myeloma. Studies have shown that tumors with Ras mutations can be resistant to conventional chemotherapy as well as approved targeted agents. However, there are no approved products that are specifically directed towards Ras mutations.
GlobeImmune is a biopharmaceutical company focused on developing therapeutic products for cancer and infectious diseases based on its proprietary Tarmogen platform. Tarmogens activate the immune system by stimulating cellular immunity, known as T cell immunity, in contrast to traditional vaccines, which stimulate predominately antibody production. To date, Tarmogen product candidates have been generally well tolerated in clinical trials for multiple disease indications and are efficient to manufacture. In May 2009, the company entered into a collaboration agreement with Celgene Corporation focused on the discovery, development and commercialization of product candidates for the treatment of cancer. In October 2011, the company entered into a worldwide, strategic collaboration with Gilead Sciences, Inc. to develop Tarmogens for the treatment of chronic hepatitis B infection. For additional information, please visit the company’s website at www.globeimmune.com.
Safe Harbor Statement
This press release and the anticipated presentation may contain “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential for the Company’s product candidates to target pancreas cancer, the Company’s ability to successfully complete clinical trials, timing and eventual prospects for approval to market any of the Company’s products and the prospects for the Company’s collaborations. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. The Company disclaims any intent or obligation to update these forward-looking statements.
David Apelian, M.D., Ph.D., M.B.A.
Chief Medical Officer